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The ESMO/SIOG Cancer in the Elderly Working Group pragmatic strategies for clinical trial designs and endpoints in older adults with cancer
- Feb 23, 2026
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The ESMO/SIOG Cancer in the Elderly Working Group pragmatic strategies for clinical trial designs and endpoints in older adults with cancer
World Health Assembly Resolution WHA78.13 "Strengthening Medical Imaging Capacity": Impact on Nuclear Medicine Globally.
Medical imaging and nuclear medicine are fundamental techniques used in today’s health care for diagnosing and treating diseases, with a measurable impact on saving patients’ lives. However, the global availability of nuclear medicine is markedly different between high-income and low- and middle
Read moreInnovative Research Organization to Facilitate Clinical Trials Implementation in the Era of Molecular Oncology: The Spiderweb Model of the Oncodistinct Network.
Response assessment in advanced differentiated thyroid cancer.
Phase IV international prospective validation of the EORTC patient satisfaction core questionnaire (EORTC PATSAT-C33) and outpatient module (EORTC OUT-PATSAT7)
BackgroundAdvances in cancer care require ongoing monitoring of patient satisfaction using rigorous questionnaires. The EORTC Quality of Life Group has cross-culturally developed a patient satisfaction core questionnaire (PATSAT-C33) to be used in any hospital cancer care settings and an outpatient satisfaction module (OUT-PATSAT7) to address specific aspects of ambulatory care. This multi-center international prospective study aimed to validate the PATSAT-C33 and OUT-PATSAT7, including assessing its acceptability.MethodsPatients (N = 690) affected by any cancer site or stage equally distributed by age and gender, were enrolled in in- and out-patient cancer settings from 20 institutions, 12 countries and 5 geographic/cultural areas. Among them, 675 completed the PATSAT-C33 alongside the EORTC QLQ-C30, Oberst’s perception of care quality 5-item, and ‘intention to recommend the hospital’ 1-item. Among the 532 outpatients, 526 also completed the OUT-PATSAT7. A subset completed a two-week retest (N = 120 & 96 for the PATSAT-C33 & OUT-PATSAT7, respectively) or one-year responsiveness-to-change assessment (RCA) (N = 166 & 155). Comprehensive psychometric testing was performed.ResultsFull item completion was high (85% & 88%), 83% of patients took ≤ 20 min to complete both questionnaires (40 items); 5% of patients required help with understanding questionnaire items. Confirmatory factor analyses evidenced satisfactory fit on the eleven PATSAT-C33 and two OUT-PATSAT7 multi-item scales (CFI/TLI > 0.90; RMSEA < 0.10 and = 0.108, respectively). Internal consistency was good to excellent (all ≥ 0.80); test–retest reliability was fair (0.48, 1 scale), good (0.60–0.74, 11 scales) to excellent (≥ 0.75, 7 scales). Convergent validity was supported by correlations of ≥ 0.40 with related Oberst’s scales and < 0.30 with unrelated QLQ-C30 scales. Known-groups differences was shown for comorbidity, toxicity, global health, care expectations and intention to recommend the hospital. Change over time was captured in groups defined based on change in global health, cancer care setting, and the receipt of supportive care over the past year.ConclusionsThis study supports the psychometric robustness of the EORTC PATSAT-C33 and OUT-PATSAT7 and their promising usefulness in monitoring cancer care within and across cancer care settings from different cultures and cancer patient populations.Trial registrationClinicalTrials.gov ID: NCT05989191, August 2, 2023.Supplementary InformationThe online version contains supplementary material available at 10.1186/s12885-025-15119-3.
Read moreTotal Neoadjuvant Therapy for Locally Advanced Rectal Cancer
This was a clinical study of total neoadjuvant therapy (TNT) for rectal cancer. To assess the use and outcomes of TNT in routine practice. This international, multicenter study was conducted at 61 centers across 21 countries and included consecutive patients treated off trial with TNT for stage II/III rectal adenocarcinoma from September 2012 to December 2023. Data were analyzed between August and October 2024. TNT, defined as the delivery of radiotherapy and nonradiosensitizing chemotherapy before surgery or watch and wait. The primary outcome was type of TNT administered. Secondary outcomes were patient characteristics, treatment adherence, safety, and efficacy overall and by type of TNT in the entire population and after propensity vector matching. A total of 1585 patients (588 female [37.1%]; median [IQR] age, 61 [53-68] years) were included, 1260 (79.5%) of whom had 1 or more high-risk features (eg, cT4, cN2, extramural venous invasion, threatened/involved mesorectal fascia, and lateropelvic lymphadenopathy). Patients were treated with the PRODIGE 23-like regimen (FOLFIRINOX/FOLFOXIRI followed by long-course chemoradiotherapy) (271 [17.7%]), RAPIDO-like regimen (short-course radiotherapy followed by consolidation FOLFOX/CAPOX) (529 [33.4%]), OPRA induction-like (induction FOLFOX/CAPOX followed by long-course chemoradiotherapy) (190 [12.0%]), OPRA consolidation-like (long-course chemoradiotherapy followed by consolidation FOLFOX/CAPOX) (257 [16.2%]), and other regimens (360 [22.7%]). After TNT, 192 (12.1%) underwent watch and wait, and 30 (1.9%) underwent local excision. Pathological or clinical complete response was reported in 23.2% of cases. At treatment failure, 8.5% was local and 16.4% was distant progression. Three-year event-free survival (EFS) was 68% (95% CI, 64%-71%), and 5-year overall survival (OS) was 79% (95% CI, 75%-83%). In the overall population, patients treated with the PRODIGE 23-like regimen were most likely to have serious adverse events (61 [23.5%]) but had better local control and survival outcomes than those treated with the RAPIDO-like (EFS: hazard ratio [HR], 0.68; 95% CI, 0.49-0.95; P = .03; OS: HR, 0.51; 95% CI, 0.27-0.97; P = .04), OPRA induction-like (EFS: HR, 0.66; 95% CI, 0.44-0.98; P = .04; OS: HR, 0.35; 95% CI, 0.18-0.70; P = .003), and OPRA consolidation-like (EFS: HR, 0.64; 95% CI, 0.44-0.93; P = .02; OS: HR, 0.50; 95% CI, 0.25-1.00; P = .05) regimens. In the matched population (928 patients [58.5%]), no differences in survival outcomes were observed between the TNT regimens. The findings of this case series study show substantial variation in the choice of the TNT regimen and were overall aligned with those reported in clinical trials, suggesting the efficacy of TNT in a clinical setting regardless of the specific regimen.
Read more496P Fertility preservation practices at gastrointestinal (GI) oncology in Europe: A Pan-European study
Behavioral and Psycho-Emotional mHealth Interventions for Elderly Breast Cancer Patients with Cardiac Toxicity.
The CARDIOCARE project combines psycho-emotional and behavioral interventions into a mobile health (mHealth) application for the elderly breast cancer patients who have a risk for therapy-induced cardiac toxicity. The mHealth application includes psycho-emotional modules such as Expressive Writing, the ABCDE Model, and Best Possible Self alongside behavioral interventions like prompted voiding and pelvic floor exercises, which are focused on both improving psychological resilience and physical health. By focusing on both physical and psychological needs, the app aims to improve patient adherence to treatment and to alleviate healthcare burden. Preliminary results based on data analysis collected from 67 patients from six clinical centers show promising trends: 45% of patients initially expressed denial in their first entries using the ABCDE module, which later shifted towards acceptance and active coping strategies. These findings show the potential of the CARDIOCARE interventions to enhance the well-being in elderly cancer patients. Ongoing trials are expected to provide a more comprehensive understanding of these interventions and their impact on improving psychological well-being and overall quality of life of cancer patients.Clinical Relevance- This study investigates the potential of the CARDIOCARE mHealth application to address both psychological and physical needs in elderly cancer patients with therapy-induced cardiac toxicity. Preliminary results from six clinical centers indicate that the CARDIOCARE mHealth application can support elderly cancer patients by helping them to express their emotions, cope with their illness, and adopt healthy routines. These interventions could help clinicians enhance patient care by providing personalized support and remote monitoring, resulting in better quality of life outcomes.
Read moreQuality of life and adherence to healthy lifestyle factors among breast cancer survivors in Cyprus
Abstract Breast cancer is a prevalent disease for women globally, with rising survival rates highlighting the need to address the breast cancer survivors’ (BCS) quality of Life (QoL). Furthermore, adherence to a healthy lifestyle is associated with decreased mortality in BCS. Mapping the Lifestyle Medicine pillars and the World Cancer Research Fund/American Institute for Cancer Research recommendations identifies 7 healthy lifestyle components: weight management, physical activity, healthy eating, restorative sleep, avoidance of risky substances, positive social connections and stress management. This study examines adherence to these healthy lifestyle components and QoL among BCS. A cross-sectional study conducted in 2022-23 recruited primary adult BCS from the Bank of Cyprus Oncology Centre. Participants completed a survey assessing self-reported QoL and adherence to the aforementioned 7 healthy lifestyle components, through validated questionnaires. Out of 349 BCS approached, 272 were included in the final analysis. Mean age and time since main treatment completion were 51 (SD: 7.4) and 3.6 (SD: 2.5) years respectively. Amongst study participants 58% were classified as bad sleepers, 53.3% were overweight or obese, 23% were stressed, 78% reported to have moderate/high physical activity, and 60% adhered to the Mediterranean diet. Regarding substance use, 16% were current smokers, and 18% were hazardous drinkers. Median score for social support was 75 (IQR: 53-97; max score=100) and for QoL was 67 (IQR: 50-97; max score:100). BCS in Cyprus generally exhibit moderate adherence to the Mediterranean diet, engage in fairly active lifestyles and enjoy high levels of social support and QoL. On the other hand, a substantial proportion smoke or drink, are overweight or obese, are stressed and have poor sleep quality. Targeted interventions to increase the adherence of breast cancer survivors to the 7 healthy lifestyle components are required. Key messages • Overall variability exists in the adherence to healthy lifestyle components among BCS in Cyprus. • This population can benefit from intervention targeting sleep, stress and weight management.
Read moreAn interdisciplinary ecosystem for the psychosocial and behavioural management of Cardiotoxicity in elderly breast cancer patient: a prospective clinical study (Preprint)
BACKGROUND Over 50% of newly diagnosed breast cancer patients are 65+ years old. Due to age-related factors and the presence of comorbidities, these patients are particularly vulnerable to developing cardiac toxicity associated with cancer treatments, which may lead to suboptimal interventions and undertreatment, resulting in poorer health outcomes, Quality of Life (QoL) deterioration and increased healthcare costs. Given the underrepresentation of elderly breast cancer patients in clinical trials and the increasing recognition of psycho-social and behavioural factors’ impact on cardiovascular (CV) disease onset, broader and interdisciplinary studies are required to develop new and innovative best practices for this clinical population. OBJECTIVE Using an innovative eHealth approach combining the CARDIOCARE (CARDIOCARE – “An Interdisciplinary Approach for the Management of the Elderly Multimorbid Patient with Breast Cancer Therapy Induced Cardiac Toxicity” – Grant Agreement 945175) Mobile App and technologically advanced wearable devices (i.e., the Garmin Venu SQ watch and the Polar h10), the CARDIOCARE prospective study pursues a twofold aim: 1) testing the effectiveness of the CARDIOCARE mobile App to monitor and assess elderly breast cancer patients’ intrinsic capacity and QoL and evaluating CARDIOCARE eHealth interventions effectiveness on these parameters 2) developing a holistic, patient-centred risk prediction model, specific for the detection of cardiotoxicity before it clinically emerges. METHODS The study is prospective and multicentric and involves six clinical and five technical partners across Europe. Seven hundred fifty elderly breast cancer patients (≥ 60years old) are randomised into either the intervention group or the control arm, with only patients in the former receiving access to eHealth psychological, behavioural, and functional interventions implemented on the CARDIOCARE eHealtHeart App. Patients will be recruited in the six clinical centres and will undergo clinical procedures to collect multi-modal data including clinical data, cardiac imaging, biochemical and psychological biomarkers and omics, intrinsic capacity, and QoL indicators, measured at baseline (T0) and every three months, up to 12 months (T5). RESULTS CARDIOCARE is a project funded by Horizon 2020 and enrollment (WP4) started in May 2023. Recruitment and first data analysis are currently underway. CONCLUSIONS The CARDIOCARE prospective study will contribute to developing new best practice guidelines for managing elderly multimorbid breast cancer patients while preserving their intrinsic capacity and improving their QoL. Furthermore, the CARDIOCARE Mobile App and the wearable devices will allow clinicians to identify trajectories across the cardiotoxicity disease continuum and thus intervene in a preventative way on higher-risk patients. Such a healthcare approach will also benefit the healthcare system, which currently spends almost 40% of its resources on patients over 60, with long-term care and hospital admissions being the primary cost drivers. CLINICALTRIAL NCT06334445
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